The Clinical Efficacy And Safety Of SkinStylus Microneedling System
Primary Purpose
Cicatrix, Hypertrophic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SkinStylus Sterilock System
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrix, Hypertrophic
Eligibility Criteria
Inclusion Criteria:
- at least 23 years old
- shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
- The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.
Exclusion Criteria:
- Pregnancy or chance of pregnancy
- Currently taking Coumadin/Warfarin® or heparin
- Diagnosis of any type of bleeding disorder
- Any history of keloid formation
- Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
- Diagnosis of mental disorders requiring inpatient treatment
- Presence of metal implants around the proposed treatment areas
- Diagnosis of any undefined wasting disease (Cachexia for example)
- Diagnosis of an active infection in the treatment area other than mild acne
- Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
- Diagnosis of severe cardiovascular and cerebrovascular disease
- Diagnosis of renal failure
Sites / Locations
- Esthetic Education LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.
Outcomes
Primary Outcome Measures
Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar.
A panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.
Secondary Outcome Measures
Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey
The Self-Assessed Scar Improvement Scale is a validated 6-point scale (-1 to 4) describing the patient's opinion regarding the overall improvement of the scar after treatment with "4" constituting the patient believing that the scar had a "75%-99%" improvement, "3" constituting a "50%-75%" improvement, "2" constituting a "25%-50%" improvement, "1" constituting a "1%-25%" improvement, "0" constituting "no change", and "-1" constituting an "exacerbation of the scar's appearance". A higher score means a better outcome.
Full Information
NCT ID
NCT03366194
First Posted
December 4, 2017
Last Updated
April 16, 2022
Sponsor
Esthetic Education LLC
1. Study Identification
Unique Protocol Identification Number
NCT03366194
Brief Title
The Clinical Efficacy And Safety Of SkinStylus Microneedling System
Official Title
The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esthetic Education LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.
Detailed Description
The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions for use and specifically no new risks will be introduced.
Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix, Hypertrophic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar.
Masking
None (Open Label)
Masking Description
3. The trial shall be blinded and bias minimized in that three (3) physicians who are either dermatologists or plastic surgeons (and not affiliated with the trial or Esthetic Education LLC) shall review the baseline and treatment photographs and score them using the VAS scale (Visual Analogue Scale).
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.
Intervention Type
Device
Intervention Name(s)
SkinStylus Sterilock System
Intervention Description
Microneedling device will be used to treat ventral hypertrophic scars.
Primary Outcome Measure Information:
Title
Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
Description
The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar.
A panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.
Time Frame
90 days from date of last treatment
Secondary Outcome Measure Information:
Title
Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey
Description
The Self-Assessed Scar Improvement Scale is a validated 6-point scale (-1 to 4) describing the patient's opinion regarding the overall improvement of the scar after treatment with "4" constituting the patient believing that the scar had a "75%-99%" improvement, "3" constituting a "50%-75%" improvement, "2" constituting a "25%-50%" improvement, "1" constituting a "1%-25%" improvement, "0" constituting "no change", and "-1" constituting an "exacerbation of the scar's appearance". A higher score means a better outcome.
Time Frame
90 days from date of last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
at least 23 years old
shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.
Exclusion Criteria:
Pregnancy or chance of pregnancy
Currently taking Coumadin/Warfarin® or heparin
Diagnosis of any type of bleeding disorder
Any history of keloid formation
Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
Diagnosis of mental disorders requiring inpatient treatment
Presence of metal implants around the proposed treatment areas
Diagnosis of any undefined wasting disease (Cachexia for example)
Diagnosis of an active infection in the treatment area other than mild acne
Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
Diagnosis of severe cardiovascular and cerebrovascular disease
Diagnosis of renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toni Stockton, MD
Organizational Affiliation
Principal Investigator for Esthetic Education LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Esthetic Education LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Clinical Efficacy And Safety Of SkinStylus Microneedling System
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